BIONCaRT GmbH has received approval to conduct a clinical phase I/IIa study from the responsible national higher federal authority, the Paul Ehrlich Institute. The aim of the study is to investigate the safety and initial indications of the efficacy of mesenchymal stromal cells obtained from umbilical cord tissue for the treatment of cartilage damage in the knee joint.
The clinical trial in accordance with the German Drug Law is entitled: “Phase I/IIa study to test the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint”.
BIONCaRT will conduct the study over the coming months in close collaboration with eight renowned clinics as test centers as well as the partner institutions Fraunhofer Institute for Cell Therapy and Immunology (IZI), which is responsible for producing the clinical test samples under GMP, Polski Bank Komórek Macierzystych (PBKM) and the Coordination Center for Clinical Studies (KKS) Dresden at TU Dresden. Prof. Dr. med. Jörg Lützner, University Center for Orthopaedics, Trauma & Plastic Surgery, Carl Gustav Carus University Hospital, TU Dresden, will lead the study.
“The approval of this study is a significant milestone for BIONCaRT and our partners. It brings us closer to our goal of providing all patients of all ages with access to cell-based regenerative therapies,” says Dr. André Gerth, CEO of BIONCaRT. “We would like to thank the regulatory authority for their trust and our partners for their committed and competent cooperation.”
This study is another important step for BIONCaRT on the path to clinical translation of innovative cell-based therapies. The results of the Phase I/IIa trial will be decisive for the further development program and the approval process.
“As a local venture capitalist, we are delighted to be able to support BIONCaRT, a Central German life science company, on its path to clinical translation. The study that has now been launched is an important step for the development of novel, cell-based therapies and at the same time strengthens Saxony and Thuringia as a biotechnology location.” — Katja Butzmann, Managing Director, bm|t Beteiligungsmanagement Thüringen GmbH & Oliver Latz, Senior Investment Manager, TGFS Technologiegründerfonds Sachsen
About BIONCaRT
As a research-based pharmaceutical company, BIONCaRT focuses on the development of cell therapy drugs for clinical use in humans, particularly for the treatment of orthopaedic diseases. The focus is primarily on allogeneic therapy concepts. The company’s main focus is on the development, approval and manufacture of stem cell-based drug products.